Reactive Intragastric Implant Devices

ABSTRACT

Transoral implantable devices includes an inflatable body made of a material that permits it to be compressed into a substantially linear transoral delivery configuration and that when implanted in the stomach is adapted to reduce obesity or weight by stimulating the stomach walls of the patient. The body has a plurality of popout features on its surface that reside generally flush with the inflatable body in relaxed, refracted states, and which respond to an increase in pressure within the inflatable body by projecting outward from the body in a stressed, deployed state. The popout features may convert between their retracted and deployed states by movement of rolling diaphragms formed in the inflatable body.

RELATED APPLICATIONS

This application is a divisional of U.S. Ser. No. 13/276,182, filed Oct.18, 2011, which claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 61/394,708, filed Oct. 19, 2010, to U.S.Provisional Application No. 61/394,592, filed Oct. 19, 2010, and to U.S.Provisional Application No. 61/394,145, filed Oct. 18, 2010, thedisclosures of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention generally relates to medical implants and usesthereof for treating obesity and/or obesity-related diseases and, morespecifically, to transorally-delivered devices designed to occupy spacewithin a stomach and/or stimulate the stomach wall and react to changingconditions within the stomach.

BACKGROUND OF THE INVENTION

Over the last 50 years, obesity has been increasing at an alarming rateand is now recognized by leading government health authorities, such asthe Centers for Disease Control (CDC) and National Institutes of Health(NIH), as a disease. In the United States alone, obesity affects morethan 60 million individuals and is considered the second leading causeof preventable death. Worldwide, approximately 1.6 billion adults areoverweight, and it is estimated that obesity affects at least 400million adults.

Obesity is caused by a wide range of factors including genetics,metabolic disorders, physical and psychological issues, lifestyle, andpoor nutrition. Millions of obese and overweight individuals first turnto diet, fitness and medication to lose weight; however, these effortsalone are often not enough to keep weight at a level that is optimal forgood health. Surgery is another increasingly viable alternative forthose with a Body Mass Index (BMI) of greater than 40. In fact, thenumber of bariatric surgeries in the United States was estimated to beabout 400,000 in 2010.

Examples of surgical methods and devices used to treat obesity includethe LAP-BAND® (Allergan Medical of Irvine, Calif.) gastric band and theLAP-BAND AP® (Allergan). However, surgery might not be an option forevery obese individual; for certain patients, non-surgical therapies orminimal-surgery options are more effective or appropriate.

In the early 1980s, physicians began to experiment with the placement ofintragastric balloons to reduce the size of the stomach reservoir, andconsequently its capacity for food. Once deployed in the stomach, theballoon helps to trigger a sensation of fullness and a decreased feelingof hunger. These devices are designed to provide therapy for moderatelyobese individuals who need to shed pounds in preparation for surgery, oras part of a dietary or behavioral modification program. These balloonsare typically cylindrical or pear-shaped, generally range in size from200-500 ml or more, are made of an elastomer such as silicone,polyurethane, or latex, and are filled with air, an inert gas, water, orsaline.

One such inflatable intragastric balloon is described in U.S. Pat. No.5,084,061 and is commercially available as the BioEnterics IntragastricBalloon System (“BIB System,” sold under the trademark ORBERA). The BIBSystem comprises a silicone elastomer intragastric balloon that isinserted into the stomach and filled with fluid. Conventionally, theballoons are placed in the stomach in an empty or deflated state andthereafter filled (fully or partially) with a suitable fluid. Theballoon occupies space in the stomach, thereby leaving less roomavailable for food and creating a feeling of satiety for the patient.Placement of the intragastric balloon is non-surgical, trans-oral,usually requiring no more than 20-30 minutes. The procedure is performedgastroscopically in an outpatient setting, typically using localanesthesia and sedation. Placement of such balloons is temporary, andsuch balloons are typically removed after about six months. Removing theballoon requires deflation by puncturing with a gastroscopic instrument,and either aspirating the contents of the balloon and removing it, orallowing the fluid to pass into the patient's stomach. Clinical resultswith these devices show that for many obese patients, the intragastricballoons significantly help to control appetite and accomplish weightloss.

Some attempted solutions for weight loss by placing devices in thestomach result in unintended consequences. For instance, some devicestend to cause food and liquid to back up in the stomach, leading tosymptoms of gastroesophageal reflux disease (GERD), a condition in whichthe stomach contents (food or liquid) leak backwards from the stomachinto the esophagus. Also, the stomach acclimates to some gastric implantdevices, leading to an expansion of stomach volume and consequentreduction in the efficacy of the device.

Therefore, despite many advances in the design of intragastric obesitytreatment implants, there remains a need for improved devices that canbe implanted for longer periods than before or otherwise address certaindrawbacks of intragastric balloons and other such implants.

SUMMARY OF THE INVENTION

Transoral three-dimensionally orthogonal intragastric spring devicesgenerally promote a feeling of satiety in the patient by contacting theinsides of the stomach wall. In addition, transoral three-dimensionallyorthogonal intragastric spring devices generally allow for easy andquick placement and removal. Surgery is usually not required or veryminimal. In one embodiment, the transoral three-dimensionally orthogonalintragastric spring devices may be placed in the patient's stomachthrough the mouth, passing the esophagus and reaching the destination.The transoral three-dimensionally orthogonal intragastric spring devicesdo not require suturing or stapling to the esophageal or stomach wall,and remains inside the patient's body for a lengthy period of time(e.g., months or years) before removal.

Each of the disclosed devices is formed of materials that will resistdegradation over a period of at least six months within the stomach. Theimplantable devices are configured to be compressed into a substantiallylinear transoral delivery configuration and placed in a patient'sstomach transorally without surgery to treat and prevent obesity byapplying a pressure to the patient's stomach.

In one embodiment, a transoral three-dimensionally orthogonalintragastric spring device may fight obesity or reduce weight bystimulating the stomach walls of the patient. The three-dimensionallyorthogonal intragastric spring device may be a purely mechanical devicecomprising a flexible body which in response to an input force in onedirection, may deform and cause a resultant displacement in anorthogonal direction, thereby exerting a pressure on the inner stomachwalls of the patient.

In another embodiment, a transoral three-dimensionally orthogonalintragastric spring device may include a variable size balloon. Theballoon may be configured to occupy volume in the patient's stomach,thereby reducing the amount of space in the patient's stomach.

In a particular embodiment disclosed herein, a reactive implantabledevice comprises a three-dimensional spring structure comprising aplurality of legs each having opposite ends extended between top andbottom junctions of the spring structure defining an axis. Each leg hasa flexible portion and a rigid portion attached to the flexible portion,wherein the flexible portions of each leg has a relaxed shape whichcauses the leg to bow laterally outward from the other legs thusmaintaining the top and bottom junctions at a first distance apart. Theimplantable device is configured to react to inward forces from thestomach such that the flexible portions flex to straighten each leg andcause the axial spacing between the top and bottom junctions to increasefrom the first distance. The implantable device may have four or morelegs, and the rigid portion comprises four or more distinct rigidmembers per leg. Each of the top and bottom junctions preferablycomprises a quadrilateral-shaped cap, wherein the opposite ends of eachleg are attached to different edges of the respectivequadrilateral-shaped caps.

In one embodiment, a balloon is integrated with the three-dimensionalspring structure and filled with fluid. The balloon may be within oroutside the legs of the three-dimensional spring structure. If outside,the device may further include a pump located within the balloon andintegrated with the three-dimensional spring structure configured toinflate and deflate the elastic balloon by transferring stomach liquidinto and out of the elastic balloon.

Another reactive implantable device disclosed herein comprises a centralelongated body having an adjustable length. Two collapsible atraumaticfeet on opposite ends of the elongated body are configured to exertpressure on the patient's stomach when in a deployed position. A springwithin the central elongated body biases the length of the body awayfrom a minimum length. The two collapsible atraumatic feet may compriseballoon-like structures. The two collapsible atraumatic feet mayalternatively comprise an array of living hinges that may be unfolded toan elongated delivery configuration and folded outward to a deployedconfiguration. In one embodiment, the array of living hinges is in anX-shape. The central elongated body preferably comprises a series oftelescoping tubular members having apertures along their lengths.

A still further reactive implantable device includes an inflatable bodyhaving an internal volumetric capacity of between 400-700 ml and beingmade of a material that permits it to be compressed into a substantiallylinear transoral delivery configuration and that will resist degradationover a period of at least six months within the stomach. The body has aplurality of popout features on its surface that reside generally flushwith the inflatable body in relaxed, retracted states, and which respondto an increase in pressure within the inflatable body by projectingoutward from the body in a stressed, deployed state. The inflatable bodymay have a generally barrel shape along an axis. The popout features maybe generally cylindrical, or are rounded bars oriented parallel to theaxis. The popout features preferably convert between their retracted anddeployed states by movement of rolling diaphragms formed in theinflatable body.

A still further reactive implantable device disclosed herein has aninflatable body with an internal volumetric capacity of between 400-700ml and being made of a material that permits it to be compressed into asubstantially linear transoral delivery configuration and that willresist degradation over a period of at least six months within thestomach. The body has a central inflatable member and at least two outerwings, and a single internal fluid chamber such that fluid may flowbetween the central inflatable member and the outer wings. Theinflatable body is underfilled with fluid such that the outer wings arefloppy in the absence of compressive stress on the central inflatablemember and stiff when compressive stress from the stomach acts on thecentral inflatable member. The central inflatable member may have agenerally spherical shape along an axis. There are preferably two outerwings extending in opposite directions from the generally sphericalinflatable member along the axis. In one form, each of the outer wingsincludes a narrow shaft portion connected to the central inflatablemember terminating in bulbous heads.

The invention also comprises a reactive implantable device configuredfor transoral placement into a patient's stomach for the treatment ofobesity by applying a pressure to the patient's stomach, the implantabledevice comprising: a spring or spring type structure having a pluralityof legs each leg having opposite ends extended between top and bottomjunctions of the spring thereby defining an axis, each leg also having aflexible portion and a rigid portion attached to the flexible portion,wherein the flexible portions of each leg has a relaxed shape whichcauses the leg to bow laterally outward from the other legs to therebymaintain the top and bottom junctions at a first distance apart, andwherein the implantable device is configured to react to inward forcesfrom the stomach such that the flexible portions flex to straighten eachleg and cause the axial spacing between the top and bottom junctions toincrease from the first distance, wherein the device is formed ofmaterials that permit it to be compressed into a substantially lineartransoral delivery configuration and that will resist substantiallyresist degradation over a period of at least six months within thestomach. To substantially resist degradation means that when placed inthe acid environment of the stomach the device still functions at leastsubstantially as intended, that is a clinically significant result (i.e.weight loss or the maintenance of a weight loss) can still be obtained.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed descriptions are given by way of example, but notintended to limit the scope of the disclosure solely to the specificembodiments described herein, may best be understood in conjunction withthe accompanying drawings in which:

FIG. 1 illustrates a perspective view of a reactive intragastric implantcomprising a three-dimensionally orthogonal intragastric spring devicein accordance with one or more embodiments described herein;

FIG. 2A illustrates a rigid member of a three-dimensionally orthogonalintragastric spring device as in FIG. 1;

FIG. 2B illustrates a rigid member molded to the three-dimensionallyorthogonal intragastric spring device of FIG. 1;

FIG. 2C illustrates an uncapped three-dimensionally orthogonalintragastric spring device of FIG. 1;

FIG. 2D illustrates a three-dimensionally orthogonal intragastric springdevice as in FIG. 1 in a deformed geometry;

FIG. 3 illustrates a flow diagram describing the steps of manufacture ofa three-dimensionally orthogonal intragastric spring device inaccordance with one or more embodiments described herein;

FIG. 4A illustrates a three-dimensionally orthogonal intragastric springdevice as in FIG. 1 with input forces in a first direction and theresultant displacement;

FIG. 4B illustrates a three-dimensionally orthogonal intragastric springdevice as in FIG. 1 with input forces in a second direction and theresultant displacement;

FIG. 4C illustrates a three-dimensionally orthogonal intragastric springdevice as in FIG. 1 with input forces in a third direction and theresultant displacement;

FIG. 5A illustrates a three-dimensionally orthogonal intragastric springdevice with an external intragastric balloon in accordance with one ormore embodiments described herein;

FIG. 5B illustrates a three-dimensionally orthogonal intragastric springdevice with an internal intragastric balloon in accordance with one ormore embodiments described herein;

FIG. 6 illustrates a perspective view of another embodiment of thethree-dimensionally orthogonal intragastric spring device as in FIG. 1with a variable size external balloon inflated;

FIG. 7 illustrates a perspective view of an alternative reactiveintragastric implant inside a patient's stomach having an elongatedspring-biased shaft with soft, folded feet;

FIG. 8 illustrates a perspective view of the reactive intragastricimplant of FIG. 7 showing exemplary spring-biasing structure therein;

FIGS. 9A-9C are perspective and sectional views of an alternativereactive intragastric implant comprising a generally barrel-shapedinflatable member having “pop-out” surface features in refractedpositions, while FIGS. 10A-10C are equivalent views with the pop-outsurface features in extended positions;

FIGS. 11A-11C are sectional views through one of the pop-out surfacefeatures illustrating a preferred rolling diaphragm wall structureenabling movement from the retracted to the extended position;

FIGS. 12A-12C are perspective and sectional views of a furtherbarrel-shaped inflatable intragastric implant having elongated “pop-out”surface features in retracted positions, while FIGS. 13A-13C show theelongated pop-out surface features in extended positions;

FIG. 14 illustrates another a reactive intragastric implant comprisingan underfilled inflatable member having outer wings that transitionbetween floppy to stiff configurations;

FIGS. 15A-15B show the intragastric implant of FIG. 14 implanted in thestomach in both relaxed and squeezed states, showing the transition ofthe outer wings between floppy and stiff configurations;

FIGS. 16 and 17 illustrate intragastric devices that encouragerotational variation; and

FIGS. 18 and 19 illustrate intragastric devices that both encouragerotational variation and provide additional stomach cavity stimulation.

DESCRIPTION OF THE DETAILED EMBODIMENTS

Persons skilled in the art will readily appreciate that various aspectsof the disclosure may be realized by any number of methods and devicesconfigured to perform the intended functions. Stated differently, othermethods and devices may be incorporated herein to perform the intendedfunctions. It should also be noted that the drawing FIGS. referred toherein are not all drawn to scale, but may be exaggerated to illustratevarious aspects of the invention, and in that regard, the drawing FIGS.should not be construed as limiting. Finally, although the presentdisclosure may be described in connection with various medicalprinciples and beliefs, the present disclosure should not be bound bytheory.

By way of example, the present disclosure will reference certaintransoral three-dimensionally orthogonal intragastric spring device.Nevertheless, persons skilled in the art will readily appreciate thatthe present disclosure advantageously may be applied to one of thenumerous varieties of three-dimensionally orthogonal intragastric springdevices.

In one embodiment, these three-dimensionally orthogonal intragastricspring device described herein are intended to be placed inside thepatient, transorally and without invasive surgery, without associatedpatient risks of invasive surgery and without substantial patientdiscomfort. Recovery time may be minimal as no extensive tissue healingis required. The life span of these transoral three-dimensionallyorthogonal intragastric spring devices may be material-dependent uponlong-term survivability within an acidic stomach, but is intended tolast one year or longer.

FIG. 1 illustrates one embodiment of a transoral three-dimensionallyorthogonal intragastric spring device, namely spring device 100. Thespring device 100 features a plurality of legs 125 having opposite endsextending between upper and lower junctions 115, 120. The legs 125 eachinclude rigid portions 105 integrated with flexible or elastic portions110. The elastic portions 110 extend the entire length of the legs 125and essentially form the legs, with the rigid portions 105 beingembedded or otherwise intimately attached thereto. In the illustratedembodiment, the spring device 100 has two rigid portions 105 for everyleg 125. More particularly, one rigid portion 105 may be embedded withinthe flexible portions 110 in the top half of the leg 125, and a secondrigid portion 105 may be embedded within the flexible portions 110 ofthe second half of the leg 125. In one embodiment, the rigid portions105 have substantially the same thickness as the flexible portion 110,and extend a short distance along each leg. As there are four legs 125shown, a total of eight rigid portions 105 may be included in thisembodiment of the spring device 100. The elastic portion 110 of each leg125 primarily controls the bending flexibility of the leg, while therigid portions 105 contribute rigidity to certain areas. In theillustrated configuration, therefore, the flexible portions 110 arerelatively unconstrained at their top and bottom ends, and in a middlesection between the upper and lower rigid portions 105.

The legs 125 are attached and held together by the top and bottomjunctions 115 and 120, respectively. The junctions 115, 120 desirablycomprise top and bottom caps. As shown, the caps forming the junctions115 and 120 are quadrilateral in configuration and each leg 125 attachesto a different one of the four sides of the caps 115 and 120. As shown,the spring device 100 is in a natural state and fully functional. Thatis, the shape shown in FIG. 1 is the relaxed shape of the device 100,with the elastic portions 110 of each leg 125 in equilibrium and notunder any bending stress.

In one embodiment, the materials used to construct the spring device 100may include metals, thermoplastics, thermoplastic elastomers, silicones,glass, thermosets or any combination thereof. More particularly, therigid portions 105 may be made of a more rigid material such as a silveralloy or glass, while the flexible portions 110 may be constructed outof elastomeric materials. If silver is used, the rigid portions 105provide an antiseptic benefit to the device 100 to prevent bacteria fromgrowing. The junction caps 115 and 120 may also be constructed out ofrigid materials. In one embodiment, the flexible portions 110 may beconstructed out of one material, while the rigid portions 120 and thejunction caps, 115 and 120, are constructed out of a second material.

In the embodiment illustrated in FIGS. 2A-2D, each rigid portion 105comprises a pair of rigid strips 205 embedded within or otherwisesecured along the corresponding flexible portion 210. A single rigidportion 205 is shown in FIG. 2A. Each rigid portion 205 appears asparallel, unattached strips that attach in parallel pairs along oppositecircumferential sides of the host flexible portion 210. Preferably, therigid portions 205 are substantially unbendable and inflexible, thoughsuch terms are relative. Alternatively, the rigid portions 205 may stillhave elastic qualities, but might not be as elastic or flexible as therest of the spring device 200, and in particular, the flexible portions210. For instance, if the flexible portions 210 are formed of anelastomer, such as silicone, then the rigid portions 205 could be silveror glass, both of which are relatively less flexible, though silverbends under the influence of greater forces and glass will eventuallycrack due to its brittle nature. However, if glass is used the smallsize of each rigid portion 205 and relatively low bending stressesimparted thereto ensures a high degree of confidence that the glass willnot break. Ceramic is another option.

FIG. 2B shows the rigid portion 205 attached or molded to the flexibleportion 210, thus forming a leg 225. As shown, the leg 225 may flex atany of the purely flexible portions 210, but are less flexible along therigid portions 205. In one embodiment, between the parallel rigidportions 205 is a portion of the flexible portion 210. In other words,the flexible portion 210 of the leg may constructed as one piece,whereas the rigid portions 205 may be constructed separately and moldedto the flexible portion 210. FIG. 2C illustrates four legs 225 arrangeduniformly with top and bottom caps. When the caps are attached, thespring device 200 is complete, and may appear similar to the springdevice 100.

FIG. 2D illustrates the spring device 200 with caps (e.g., top andbottom junction caps 215 and 220) holding the legs 225 attached inplace. Here, FIG. 2D illustrates the spring device 200 in a deformed,stressed, or straightened state. As shown, the flexible portions 210 areno longer in a curved configuration (e.g., in a natural, relaxed state),but instead is shown in a relatively straightened position. The rigidportions 205 are still substantially flat, similar to the rigid portionsas shown in FIGS. 2A-2C. Overall, the spring device 200, is flat andelongated (e.g., the distance between junction caps 215 and 220 isextended when compared to the distance between junction caps 215 and 220in the configuration of FIG. 2C). Accordingly, this position isadvantageous for inserting the spring device 200 through a patient'smouth, down the esophagus and into the patient's stomach, and can bemaintained within a delivery tube, for example.

Next, a method of manufacturing of a spring device (e.g., spring device100 or 200) will be discussed. While the following description refers tospring device 100 specifically, the same principles apply to springdevice 200 or any other embodiment of the spring device equally.

FIG. 3 illustrates a method of manufacturing a spring device 100. Atstep 305, the rigid portions or members 105 may be initially formed. Atstep 310, elastic material is overmolded on the rigid members 105. Theelastic material may comprise the flexible portions 110, and theresulting component of the rigid members 105 with the elastic materialmay be considered a leg 125. After a plurality of legs are constructed(e.g., four legs as shown in FIG. 1, but any number of legs of 2 or moremay be constructed—such as 3 legs, 5 legs, 6 legs, etc.), the legs 125may be oriented to be evenly spaced apart at step 315. At step 320, thelegs 125 may be coupled by a top cap 115 and a bottom cap 120. The endsof the legs 125 may be glued into the caps 115, 120, heat bonded,secured with fasteners, etc. In one embodiment, the caps 115, 120 arecrimped onto the ends of the legs 125. In one aspect, the top and bottomjunction caps 115 and 120 have a number of edges equal to the number oflegs. For example, as shown in FIG. 1, the top and bottom junction caps,115 and 120, have 4 edges each, one for each of the legs 125.

After formation, and well before or just prior to use, the spring device100 may be placed inside a removable sleeve, band, or otherwise held ina “deformed” or straightened position (e.g., as shown in FIG. 2D), atstep 325, and in this position, the spring device 100 may be ready forinsertion into the patient's stomach. In one embodiment, the sleeve orband holding the spring device 100 in a straightened position may beconfigured to be removable by a standard grabber. For example, the bandmay have a “snap-on” buckle that is releasable by using a standardgrabber to press on a certain portion of the buckle. Alternatively, thesleeve or band may be constructed out of a non-toxic, digestiblesubstance, such as a food or other commonly edible substance like asugar, so that the sleeve or band may be “removed” by the natural acidsinside the patient's stomach after insertion by the patient's naturaldigestion process. As a result of the digestion of the sleeve or band,the spring device 100 may revert back to an unfolded, compressedconfiguration (e.g., as shown in FIG. 1). In other words, the sleeve orband acts to decompress and elongate the spring device (e.g., springdevice 100 or 200), and the removal of the sleeve or band causes thespring device to contract.

For removal, a standard grabber may encircle the spring device 100 atthe flexible portions 110 and decompress the spring device into astraightened state for easy removal. In one embodiment, the flexibleportions 110 configured to be “grabbed” by the standard grabber todecompress the spring device 100 may be injected with a radio opaqueadditive during the construction of these portions so that the physicianmay identify and view these portions when viewing an x-ray during theremoval procedure.

Turning to FIGS. 4A-4C, the operation of the spring device 100 deployedinside the patient's stomach will be discussed. Initially, the springdevice 100 may reside in the patient's stomach in the configuration asshown in FIG. 1. As the spring device 100 begins to migrate about thepatient's stomach due to stomach contractions and/or the patient'sposition (e.g., the patient is sitting down, lying down, etc.), thespring device 100 may begin to variably rotate and may exert pressure onthe patient's stomach in some positions, while not exerting pressure onthe patient's stomach in other positions.

FIG. 4A illustrates the spring device 100 where axial compression isexerted on the spring device 100 at the location of the junction caps115 and 120 (as shown by arrows 400). The pressure exerted by thestomach walls as shown by arrows 400 causes the flexible portions 110 toflex outwards, away from one another, and as a result, the flexibleportions 110 pressure the stomach walls in a direction shown by arrows410.

In another embodiment, as shown by FIG. 4B, when lateral compression isexerted on the spring device 100 at the location of the flexibleportions 110 (as shown by arrows 420) by the stomach walls contracting,other flexible portions 110 may also compress (as shown by arrows 430)and, as a result, the junction caps 115 and 120 of the spring device 100move axially outwards in a direction shown by arrows 440 causingpressure on a different portion of the stomach walls.

Similarly, as shown by FIG. 4C, when lateral compression is exerted onthe spring device 100 at the location of the flexible portions 110 (asshown by arrows 450) by the stomach walls contracting, other flexibleportions 110 may also compress (as shown by arrows 460) and, as aresult, the junction caps 115 and 120 of the spring device 100 moveaxially outwards in a direction shown by arrows 470 causing pressure ona different portion of the stomach walls.

As described above with respect to FIGS. 4A-4C, an input pressureexerted on the spring device 100 by the inner stomach wall may result inan output pressure exerted by the spring device 100 on the inner stomachwall at a location orthogonal to the location of the input pressure.Moreover, as the spring device 100 rotates and moves around variablywithin the patient's stomach, the spring device 100 may occupy differentthree-dimensional space areas within the patient's stomach and may alsocontact and exert a pressure on the patient's stomach in any of a numberof different locations of the inner stomach wall. In this fashion, thespring device 100 limits the ability of the stomach to adapt over longterm implantation.

In different embodiments, the spring device (e.g., spring device 100 or200) may further include an intragastric balloon. FIGS. 5A and 5Billustrate two examples of such embodiments. FIG. 5A is an example of anembodiment with an external intragastric balloon 500 surrounding thespring device 100. Alternatively, as shown in FIG. 5B, an internalintragastric balloon 502 may be located inside the legs 125 of springdevice 100. Here, the intragastric balloon 502 may be held in placeinside the spring device 100 by the particular configuration of the legs125. By utilizing an intragastric balloon (e.g., 500 or 502), the springdevice 100 may also act as an effective volume occupying device insidethe patient's stomach, thereby reducing the amount of space inside thepatient's stomach to hold food. The balloons are desirablysaline-filled.

FIG. 6 illustrates another embodiment of a transoral device 504comprising an external gastric balloon 500 in conjunction with thespring device 100. Legs of the spring device 100 desirably attach and/orare integrated into a central tubular body 520 of the intragastricballoon 500. For instance, the aforementioned end caps may be rigidlyintegrated into the tubular body 520. As shown, the intragastric balloon500 may comprise a “balloon” layer 505; that is the balloon 500 may notextend completely around but may be open at opposite poles for passageof the body 520.

In one embodiment, the transoral device 504 may be considered atwo-phase intragastric device. In the first phase, the intragastricballoon 500 expands to a sufficient volume that effectively negates theimpact of the spring device 100. That is, the intragastric balloon 500may be so large that the legs of spring device 100 never contact theinside of the stomach walls. In this phase, the spring device 100 is apurely volume occupying device. In a second phase, the volume of theintragastric balloon 500 is reduced (deflated) such that the legs of thespring device 100 protrude against the “walls” or balloon layer 505 ofthe intragastric balloon 500, thereby receiving input pressures from thestomach walls during contraction, and causing the spring device 100 toreact as described above with respect to FIGS. 4A-4C. In this secondphase, the transoral device may be both a volume occupying device and aninner wall stimulating device. Since the volume of the intragastricballoon 500 may be controlled according to a schedule and/or externallyby a physician, either the first or second phase may be selected inorder to best assist the patient to lose weight based on the time of dayor in relationship to the patient consuming food. For example, duringmeals, it may be more beneficial to stimulate the stomach walls andthus, phase two may be more appropriate, but between meals, it may bemore beneficial just to have a larger volume occupied in the stomach andthus, phase one may be more appropriate. In one embodiment, thetransoral device 504 may be configured to move from a first phase to asecond phase, back to the first phase, etc. according to a schedule orother trigger.

The inflatable balloon device 504 may be inflated and filled withstomach juices naturally occurring and produced in the patient's body.At the outer surface of the top 510 of the central tubular body 520 isan opening 515 that functions as an intake for a peristaltic pump 525integrated into the body 520. The pump 525 pulls stomach juices into theinflatable layer 505 to fill and expand the balloon 500, or pushes outstomach juices from inside the inflatable layer 505 to deflate theballoon 500. Though not shown in great detail, the peristaltic pump 525includes two openings, the inlet opening 515 at the top of the body 520and an outlet opening (not shown) leading to the space within theinflatable layer 505. Peristaltic rollers 535 of the pump 525 are influid connection with flexible tubes that connect to the inlet andoutlet openings. In operation, the rollers 535 rotate in one directionto move stomach fluid from one tube to the other tube and out of outletopening 515, thereby deflating the inflatable balloon device 504.Opposite rotation of the rollers 535 pulls stomach fluid in the inletopening 515 and expels it to the cavity of the inflatable layer 505,thus inflating the balloon device 504. The inflatable balloon device 504may further include a control portion or control board 530 and motor(not shown). By inflating the inflatable balloon device 504 to a volumebetween about 0 milliliters (mL) and about 1000 mL (but preferablybetween about 400 mL and about 700 mL), the balloon device 504 occupiesspace in the stomach decreasing the amount of space for food, and alsostimulates the stomach walls when the inflatable balloon device 504 (viainflation and/or migration) exerts a pressure on the inner stomachwalls.

The rollers 535 may be controlled according to any of a number ofmethods. Initially, when the inflatable balloon device 504 is firstdeployed in the patient's stomach, the control board 530 may read aschedule (stored in memory) providing instructions related to thedifferent volumes that inflatable balloon device 504 may adjust to, andat which times. In one example, the schedule may be a daily schedulethat the inflatable balloon device 504 follows. Alternatively, theschedule may be for a week, month, year and so forth. After the scheduleis read, the target volume may be determined, and the motor may bedriven to achieve the target volume. Subsequently, the inflatableballoon device 504 may determine if a trigger to change the volume isdetected. For example, the trigger may be merely determining that theschedule dictates a changing of the volume of the inflatable balloondevice 504. Other triggers may include a command from an externalcomputer to change the volume of the inflatable balloon device 504.

A portion of the central body 520 of the inflatable balloon device 504is desirably covered by an antiseptic band 560. The band 560 may be aseparate piece of metal attached to the body 520, or may be directlyintegrated into the body 520 as an exterior layer. The band 560 may beconstructed of any material with cleansing, antiseptic qualities. In oneexample, silver may be used to form the band since silver has naturalantiseptic qualities. The function of the band 560 is to passivelydisinfect the stomach fluid inside the inflatable layer 505.

The insertion process for the inflatable balloon device 504 may be assimple as having the patient swallow the device while in a deflatedstate. Alternatively, the inflatable balloon device 504 in a deflatedstate may be carefully inserted through the mouth of the patient, downthe esophagus and into the patient's stomach by using a standardgrabber.

The removal process for the inflatable balloon device 504 may besubstantially the reverse of the insertion process. After substantiallydeflating the inflatable balloon device 504, a standard grabber may beused to clamp onto one end of the device and pulled back up through theesophagus and out the patient's mouth.

FIG. 7 illustrates an alternative reactive intragastric implant 600implanted inside a patient's stomach in a state exerting pressure on thepatient's inner stomach walls. The implant 600 comprises an elongatedspring-biased tubular shaft or body 605 with soft, folded atraumaticfeet 620 on opposite ends. The tubular body 605 preferably comprises atelescoping structure such that one end 620 attaches to a shaft portionthat moves relative to another shaft portion attached to the oppositeend, the two shaft portions being spring-biased away from a minimumlength. The intragastric implant 600 may reduce appetite as the feet 620contact and pressure the inside of the patient's stomach walls, therebyaffecting nerves and causing early feelings of satiety.

The intragastric implant 600 is configured to telescope to varyinglengths. For example, FIG. 8 illustrates the intragastric implant ofFIG. 7 in an extended position. As shown, extension portions 650attached to opposite feet 620 are sized smaller than a throughbore ofthe tubular body 605 and are arranged to slide therein. A spring 645couples to the extension portions 650 for each foot 620. Inward pressurefrom the inner stomach walls causes the implant 600 to adjustablytelescope to experience a reduction in length. When the extensionportions 650 telescope out from within the tubular body 605, the lengthof the intragastric implant 600 increases. The varying lengthintragastric implant 600 is desirably reactive in that the size changeoccurs in reaction to external stomach forces. In one embodiment, aminimum length for the intragastric implant 600 is between about 8-12cm, while a maximum length is between about 12-15 cm.

Here, no electronics are required. The benefit to this embodiment isthat no motor is required (and hence, the production of the implant 600may be cheaper). However, the trade-off is that the patient's body mayhave a higher likelihood of compensating to a spring-biased implant 600since the telescoping depends on the position of the implant and cannotchange randomly or according to a diverse schedule. Nevertheless, theaction of the reactive intragastric implant 600 is believed to besufficiently variable to prevent accommodation by the stomach.

The feet 620 may be bent to a straightened or elongated position toallow easier implantation and removal. In embodiment, the entireintragastric implant including the feet 620 (in a straightened state,not shown) may be no larger than 10 millimeters (mm) in diameter,thereby easily passing transorally into the patient's mouth, through theesophagus and into the patient's stomach. However, once implanted insidethe patient's stomach, the feet fold to the deployed state as shown inFIGS. 7 and 8. In this state, the feet point outwards and preventmigration through the pylorus, and then the intestines. In anotheraspect, removal of the reactive intragastric implant 600 may be easilyperformed using a standard grabber. Once the feet 620 are straightenedand the implant 600 is axially compressed, the entire implant 600 may beeasily pulled up through the patient's stomach and esophagus and exitthe patient's mouth.

The feet 620 are configured to be atraumatic, in that they are soft andpliable. The feet 620 are desirably formed as an array of fingers of asoft polymer, each preferably having thinned regions so as to functionlike living hinges. More particularly, each of the spokes of the “X”shaped feet 620 has a rectangular cross-section to facilitate bending inone plane, and thinned regions at three points: where it connects to therespective extension portion 650, where it connects to the other spokesalong an axis of the device, and at a mid-portion which forms theoutermost end of each of the spokes in the deployed configuration seenin FIGS. 7 and 8. When the intragastric implant 600 exerts pressure onthe stomach walls the feet 620 bend or flex back toward the tubular body605. Advantageously, even in this pressuring state, the end portion 620is not able to migrate through the pylorus. In other words, even at thepressuring state, the foot 620 is still too large to fit through thepylorus. Of course other configurations for the atraumatic feet arecontemplated, such as rounded pillows, cups, or the like. Regardless ofwhich embodiment of the reactive intragastric implant 600, the feet 620may be, for example, an acid-resistant plastic or any other appropriatematerial injected with radio-opaque additive so that they may be seenwith an x-ray machine during the removal procedure.

Furthermore, the tubular body 605 and extension portions 650 aredesirably hollow and include through holes 695 to allow stomach juicesto flow through. The tubular body 605 and extension portions 650 may beconstructed, for example, out of a polysulphone, polypropylene or anacid-resistant plastic material configured to resist the strong acidityof the stomach juices.

FIGS. 9A-9C illustrates an alternative reactive intragastric implant 700comprising a generally barrel-shaped inflatable member 702 having amultiplicity of “pop-out” surface features 704 on its surface thatreside generally flush with the inflatable body in relaxed, retractedstates, and which respond to an increase in pressure within theinflatable body by projecting outward from the body in a stressed,deployed state. The popout surface features 704 as illustrated are smallcircular dimples in the wall of the inflatable member provided in threerows spaced along an axis of the inflatable member 702. In oneembodiment, the surface features 704 in the middle row are offset fromthose in the top and bottom rows. Of course, other patterns and spacingof the surface features 704 are possible. FIGS. 10A-10C are equivalentviews with the pop-out surface features 704 in extended positions,wherein they form outwardly projecting cylinders from the remainder ofthe substantially barrel-shaped inflatable member 702.

FIGS. 11A-11C are sectional views through one of the pop-out surfacefeatures 704 illustrating a preferred rolling diaphragm wall structure.That is, each surface features 704 in its retracted position of FIG. 11Aincludes a cylindrical portion 710 that connects to the surrounding flatwall portion 712 via a 360° rolling diaphragm 714. As pressure withinthe inner chamber of the inflatable number 702 increases, thecylindrical portion 710 begins to project from the surrounding wallportion 712 as seen in FIG. 11B. This occurs by virtue of the rollingdiaphragm 714, which gradually transitions to become a part of the sideof the cylindrical portion 710. Finally, in FIG. 11C, the cylindricalportion 710 projects outward from the wall portion 712 a maximumdistance, and the rolling diaphragm 714 is at its minimum length. Ofcourse, a reduction in pressure within the inner chamber of theinflatable member 702 causes a reverse action, by virtue of theelasticity of the rolling diaphragm 714. That is, the “as-molded” shapeof each surface feature 704 is as shown in FIG. 11A, such that thedefault position is that in which the cylindrical portion 710 isretracted to be approximately level with the surrounding wall portion712.

FIGS. 12A-12C illustrates a further barrel-shaped inflatableintragastric implant 720 having elongated “pop-out” surface features 722in retracted positions, while FIGS. 13A-13C show the elongated pop-outsurface features in extended positions. In this configuration, there area total of six elongated surface features 722 arranged equidistantlyaround the circumference of the implant 720, and centrally positionedalong its axis. The surface features 722 desirably function the same asdescribed above, with rolling diaphragms permitting the bar shapedelements to ultimately project and retract relative to the surroundingwall portions. Indeed, the sectional views of FIGS. 11A-11C equallyrepresent a horizontal section through one of the bar-shaped surfacefeatures 722, at least away from its ends.

The intragastric implants 700, 720 described above are primarily volumeoccupying, similar to current gastric balloons. As such, the fill volumeis desirably the same, preferably between 400-700 mL. However, becauseof the popout surface features, the implants also provide enhancedstimulation to the surrounding stomach walls, which induces satiety.Furthermore, a number of rotationally variant intragastric implants areshown below with reference to FIGS. 16-17, and the popout features couldeasily be incorporated therein to provide further stimulation to thestomach walls.

The two embodiments of intragastric implants 700, 720 with popoutfeatures 704, 722 shown in FIGS. 9-13 are exemplary only, and numerousother configurations are contemplated. For example, the above featuresare shown as being evenly distributed over the surface of the implants,while in the alternative the features can be randomly distributed. Also,the polar ends of the barrel-shaped implant 700, 720 are shown absent ofthe popout features, though they can be provided all over the devices.Likewise, the shape of the projecting popout features 704, 722 arerelatively rounded; domed cylindrical in the first embodiment and halftubular in the second. However, more angular or pointed shapes can bemolded into the walls of intragastric implants and surrounded by rollingdiaphragms so that the resulting projections are somewhat morestimulating to the inner walls of the stomach.

Finally, a “rolling diaphragm” refers to a region surrounding each ofthe popout features that permits a projection to remain retracted untilan inner chamber of the implant is pressurized, at which time itextrudes out from the surrounding wall surfaces. The illustratedembodiment of rolling diaphragm shows a continuous transition of thediaphragm which “rolls” at a crease. Another way to define rollingdiaphragm is a surface feature that allows for a change in the outersurface shape without any change in surface area. These intragastricimplants experience bending stresses to change shape, rather thanexperiencing tensile stretching, which improve the durability of thedevices. The same function can be obtained with structure that is morehinged as opposed to rolling, such that there is a sudden transitionbetween a retracted position to a projecting position. Additionally,other popout configurations include a folded or spiral shape thatunfolds when pressurized, elements that lie flat against the wall of theimplant until pressurized, thinned regions of the wall which bow outwardfrom surrounding figure wall portions, etc. It should be understood thatthe term “popout features” encompasses all of these variations.

FIG. 14 illustrates a still further reactive intragastric implant 740comprising an underfilled central inflatable member 742 having outerwings 744 that transition between floppy to stiff configurations. Theentire implant 740 defines a single fluid chamber therein. In theillustrated embodiment, the inflatable member 742 is substantiallyspherical, while the outer wings 744 resemble stems with a narrowproximal shaft 746 terminating in a bulbous head 748. Also, a pair ofthe outer wings 744 extend from opposite poles of the sphericalinflatable member 742, which is believed to facilitate alignment of theimplant 740 within the stomach, though more than two such wingsdistributed more evenly around the inflatable member could be provided.

FIG. 15A shows the intragastric implant 740 implanted in the stomach ina relaxed state, while FIG. 15B shows the implant in a squeezed state,illustrating the transition of the outer wings 744 between floppy andstiff configurations. The shape of the central inflatable member 742 inFIG. 15B is a representation of the shape as if squeezed by thesurrounding stomach walls, however the illustrated stomach is shown inits relaxed configuration. Transition between the relaxed and squeezedstate of the implant 740 occurs when the stomach walls squeeze thecentral inflatable member 742, thus pressurizing the outer wings 744. Inother words, fluid is driven from the central member 742 and into theouter wings 744. In a certain sense, the outer wings 744 functionsimilar to the popout features, though they are always external to thecentral inflatable member 742.

Initially, the entire implant 740 is underfilled with a fluid such assaline or air to a degree that the wings 744 are floppy, and apredetermined compressive force causes them to become stiff. Forexample, the fully filled volume of the intragastric implant 740 may bebetween 400-700 mL, though the implant is filled with less than that,thus providing slack for flow into the wings 744. Additionally, itshould be noted that underfilling the implant 740 results in lowerstresses within the shell wall, which may improve the degradationproperties of the material within the stomach's harsh environment.

FIGS. 16 and 17 illustrates certain specific features that may encouragerotational variation. In FIG. 16, an intragastric obesity treatmentdevice 890 essentially comprises an aggregation of spheres 892. Theoverall exterior shape of the device is somewhat spherical, encouragingrotation. However, the outwardly projecting spheres that make up thedevice contact the stomach wall at different locations as the devicerotates. In FIG. 17, a device 900 comprises a plurality of outwardlyprojecting legs 902 terminating in rounded or bulbous feet 904. Again,the device 900 rotates relatively easily within the stomach, especiallyupon peristaltic motion, and the separated legs 902 and feet 904therefore contact the stomach wall at different locations on aconstantly changing basis. These features can be utilized in a devicethat looks like the device 900, or can be added to the number of theembodiments described herein, such as the inflated balls of FIGS. 8 and10.

The devices 890, 900 of FIGS. 16 and 17 may also serve to temporarilyblock the pylorus and slow gastric emptying. Consequently, suchprotrusions as the spheres 892 and bulbous feet 904 may be added to anumber of the devices described herein.

Another option for a number of the intragastric devices disclosed hereinis to add exterior stimulation features, such as any raised or depressedgeometry which act to stimulate certain portions of the stomach walls.Such features may be particularly effective for those embodiments whichstimulate the cardia. For instance, FIG. 18 illustrates a sphericalintragastric device 910 having numerous external bumps 912 projectingoutward therefrom. These bumps 912 separately contact the inner walls ofthe stomach, potentially increasing the stimulation to the surroundingsatiety-sensing nerves. Another example of exterior stimulation featuresis seen in FIG. 19, where an intragastric device 920 formed as a spherefeatures a multitude of small flagella 922 extending outward therefrom.It should be noted that the two embodiments shown in FIGS. 18 and 19rotate freely within the stomach, and that the bumps 912 or flagella 922may be provided in a non-uniform distribution so as to take advantage ofthe benefits of the rotational variation described above. That is, aregular array of such exterior features may stimulate the stomach wallmore than a smooth surface, but also providing a non-uniformdistribution will create different sensations on a constantly changingbasis.

It should also be stated that any of the embodiments described hereinmay utilize materials that improve the efficacy of the implant. Forexample, a number of elastomeric materials may be used including, butnot limited to, rubbers, fluorosilicones, fluoroelastomers,thermoplastic elastomers, or any combinations thereof. The materials aredesirably selected so as to increase the durability of the implant andfacilitate implantation of at least six months, and preferably more than1 year.

Material selection may also improve the safety of the implant. Some ofthe materials suggested herein, for example, may allow for a thinnerwall thickness and have a lower coefficient of friction than theimplant.

The implantable devices described herein will be subjected to clinicaltesting in humans. The devices are intended to treat obesity, which isvariously defined by different medical authorities. In general, theterms “overweight” and “obese” are labels for ranges of weight that aregreater than what is generally considered healthy for a given height.The terms also identify ranges of weight that have been shown toincrease the likelihood of certain diseases and other health problems.Applicants propose implanting the devices as described herein into aclinical survey group of obese patients in order to monitor weight loss.

The clinical studies will utilize the devices described above inconjunction with the following parameters.

Materials:

Silicone materials used include 3206 silicone for any shells, inflatablestructures, or otherwise flexible hollow structures. Any fill valveswill be made from 4850 silicone with 6% BaSo₄. Tubular structures orother flexible conduits will be made from silicone rubber as defined bythe Food and Drug Administration (FDA) in the Code of FederalRegulations (CFR) Title 21 Section 177.2600.

Purposes:

the devices are for human implant,

the devices are intended to occupy gastric space while also applyingintermittent pressure to various and continually changing areas of thestomach;

the devices are intended to stimulate feelings of satiety, therebyfunctioning as a treatment for obesity.

General Implant Procedures:

The device is intended to be implanted transorally via endoscope intothe corpus of the stomach.

Implantation of the medical devices will occur via endoscopy.

Nasal/Respiratory administration of oxygen and isoflurane to be usedduring surgical procedures to maintain anesthesia as necessary.

One exemplary implant procedure is listed below.

-   a) Perform preliminary endoscopy on the patient to examine the GI    tract and determine if there are any anatomical anomalies which may    affect the procedure and/or outcome of the study.-   b) Insert and introducer into the over-tube.-   c) Insert a gastroscope through the introducer inlet until the    flexible portion of the gastroscope is fully exited the distal end    of the introducer.-   d) Leading under endoscopic vision, gently navigate the gastroscope,    followed by the introducer/over-tube, into the stomach.-   e) Remove gastroscope and introducer while keeping the over-tube in    place.-   f) OPTIONAL: Place the insufflation cap on the over-tubes inlet,    insert the gastroscope, and navigate back to the stomach cavity.-   g) OPTIONAL: Insufflate the stomach with air/inert gas to provide    greater endoscopic visual working volume.-   h) Collapse the gastric implant and insert the lubricated implant    into the over-tube, with inflation catheter following if required.-   i) Under endoscopic vision, push the gastric implant down the    over-tube with gastroscope until visual confirmation of deployment    of the device into the stomach can be determined.-   j) Remove the guide-wire from the inflation catheter is used.-   k) If inflated: Inflate the implant using a standard BioEnterics    Intragastric Balloon System (“BIB System”) Fill kit.-   l) Using 50-60 cc increments, inflate the volume to the desired fill    volume.-   m) Remove the inflation catheter via over-tube.-   n) Inspect the gastric implant under endoscopic vision for valve    leakage, and any other potential anomalies. Record all observations.-   o) Remove the gastroscope from over-tube.-   p) Remove the over-tube from the patient.

End Point Criteria:

-   -   Weight Loss    -   Comprehensive Metabolic Panel (CMP)    -   HbA1C    -   Lipid Panel    -   Tissue Samples/Response

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe specification and attached claims are approximations that may varydepending upon the desired properties sought to be obtained. At the veryleast, and not as an attempt to limit the application of the doctrine ofequivalents to the scope of the claims, each numerical parameter shouldat least be construed in light of the number of reported significantdigits and by applying ordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the disclosure are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements.

The terms “a,” “an,” “the” and similar referents used in the context ofdescribing the invention (especially in the context of the followingclaims) are to be construed to cover both the singular and the plural,unless otherwise indicated herein or clearly contradicted by context.Recitation of ranges of values herein is merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., “such as”) provided herein isintended merely to better illuminate the invention and does not pose alimitation on the scope of the invention otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the invention.

Groupings of alternative elements or embodiments of the inventiondisclosed herein are not to be construed as limitations. Each groupmember may be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. It isanticipated that one or more members of a group may be included in, ordeleted from, a group for reasons of convenience and/or patentability.When any such inclusion or deletion occurs, the specification is deemedto contain the group as modified thus fulfilling the written descriptionof all Markush groups used in the appended claims.

Certain embodiments are described herein, including the best mode knownto the inventors for carrying out the invention. Of course, variationson these described embodiments will become apparent to those of ordinaryskill in the art upon reading the foregoing description. The inventorexpects skilled artisans to employ such variations as appropriate, andthe inventors intend for the invention to be practiced otherwise thanspecifically described herein. Accordingly, this invention includes allmodifications and equivalents of the subject matter recited in theclaims appended hereto as permitted by applicable law. Moreover, anycombination of the above-described elements in all possible variationsthereof is encompassed by the invention unless otherwise indicatedherein or otherwise clearly contradicted by context.

Furthermore, references may have been made to patents and printedpublications in this specification. Each of the above-cited referencesand printed publications are individually incorporated herein byreference in their entirety.

Specific embodiments disclosed herein may be further limited in theclaims using “consisting of or” consisting essentially of language. Whenused in the claims, whether as filed or added per amendment, thetransition term “consisting of” excludes any element, step, oringredient not specified in the claims. The transition term “consistingessentially of” limits the scope of a claim to the specified materialsor steps and those that do not materially affect the basic and novelcharacteristic(s). Embodiments of the invention so claimed areinherently or expressly described and enabled herein.

In closing, it is to be understood that the embodiments of the inventiondisclosed herein are illustrative of the principles of the presentinvention. Other modifications that may be employed are within the scopeof the invention. Thus, by way of example, but not of limitation,alternative configurations of the present invention may be utilized inaccordance with the teachings herein. Accordingly, the present inventionis not limited to that precisely as shown and described.

What is claimed is:
 1. A reactive implantable device configured to beplaced in a patient's stomach transorally without surgery to treat andprevent obesity by applying a pressure to the patient's stomach,comprising: an inflatable body having an internal volumetric capacity ofbetween 400-700 ml and being made of a material that permits it to becompressed into a substantially linear transoral delivery configurationand that will resist degradation over a period of at least six monthswithin the stomach, the body having a plurality of popout features onits surface that reside generally flush with the inflatable body inrelaxed, retracted states, and which respond to an increase in pressurewithin the inflatable body by projecting outward from the body in astressed, deployed state.
 2. The device of claim 1, wherein theinflatable body has a generally barrel shape along an axis.
 3. Thedevice of claim 2, wherein the popout features are generallycylindrical.
 4. The device of claim 2, wherein the popout features arerounded bars oriented parallel to the axis.
 5. The device of claim 1,wherein the popout features convert between their retracted and deployedstates by movement of rolling diaphragms formed in the inflatable body.6. An implantable device configured to be placed in a patient's stomachtransorally without surgery to treat and prevent obesity by applying apressure to the patient's stomach, comprising: an inflatable body havingan internal volumetric capacity of between 400-700 ml and being made ofa material that permits it to be compressed into a reduced diametertransoral delivery configuration and that will resist degradation over aperiod of at least six months within the stomach, the body having aplurality of popout features on its surface that reside generally flushwith the inflatable body in relaxed, retracted states, and which respondto an increase in pressure within the inflatable body by projectingoutward from the body in a stressed, deployed state.
 7. The device ofclaim 6, wherein the inflatable body is substantially barrel-shaped. 8.The device of claim 7, wherein the popout features are defined asdimples in an exterior wall of the inflatable body.
 9. The device ofclaim 8, wherein the dimples are provided in a plurality of rows spacedalong an axis of the inflatable body.
 10. The device of claim 9, whereinthe dimples in adjacent rows are radially offset from each other. 11.The device of claim 7, wherein the popout features form outwardlyprojecting cylinders from the remainder of the inflatable body.
 12. Thedevice of claim 6, wherein the popout features are a rolling diaphragmstructure in the surface.
 13. The device of claim 6, wherein the popoutfeatures include a projection that remains retracted until an innerchamber of the inflatable body is pressurized, at which time the popoutfeatures extrudes out from its surrounding wall surfaces.
 14. The deviceof claim 6, wherein the popout features each define a 360° crease aboutwhich the popout features roll into respective projected shapes relativeto the inflatable body.
 15. The device of claim 6, wherein the popoutfeatures extend longitudinally along an axis of the inflatable body. 16.The device of claim 6, wherein the popout features are rounded barsoriented parallel to the axis.
 17. The device of claim 6, wherein thepopout features are generally cylindrical.